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  5. Label Information: Atopalm Oral Pain Relief

FDA Label for Atopalm Oral Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR INFORMATION?
    12. LABELING INFORMATION

Atopalm Oral Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Neopharm, Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Benzocaine 10%


Purpose



Oral Pain Reliever


Use



for the temporary relief of pain due to toothaches.


Warnings



Allergy alert:

  • do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

Do Not Use



  • more than directed
  • for more than 7 days unless told to do so by a dentist or a doctor.

Stop Use And Ask A Doctor If



  • swelling, rash or fever develops
  • irritation, pain, or redness persists or worsens.

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • cut open tip of tube at score mark
    • Adults and children 2 years of age and older
    • apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or a doctor.
      • Children under 12 years of age
      • should be supervised in the use of this product.
        • Children under 2 years of age
        • ask a dentist or a doctor.

Other Information



  • do not use if tube tip is cut prior to opening
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously.

Inactive Ingredients



PEG-400, PEG-6000, Glycerin, Sodium Saccharin, Sorbic Acid, Flavor


Questions Or Information?



Call toll free 1-855 ATOPALM – (1-855-286-7256)


Labeling Information



ATOPALM Oral Pain Relief Gel

Fast Temporary Relief of Pain Due to Toothache

Benzocaine 10%


Distributed by: NeoPharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760
Made in Korea




Atopalm Oral Gel - atopalm oral tube

Atopalm Oral Gel - atopalm oral tube




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